MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036124080
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that the delivery wire of the subject coil was broken and remained inside the detachment system during the procedure.The coil which was placed in the aneurysm was retracted.Another coil was used to complete the procedure successfully.No patient consequences were reported due to this event.
Event or Problem Description
It was reported that the delivery wire of the subject coil was broken and remained inside the detachment system during the procedure.The coil which was placed in the aneurysm was retracted.Another coil was used to complete the procedure successfully.No patient consequences were reported due to this event.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The reported event is covered in the device directions for use (dfu).In addition, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.As per the additional information, there was fracture of the delivery wire which remained in the in zone.The device was not returned for analysis therefore, visual, dimensional and functional testing could not be performed.It is probable that the delivery wire fractured in an attempt to insert its proximal end into the power supply to complete the coil detachment.Therefore, an assignable cause of ¿procedural factors¿ has been assigned to this reported event.

• Brand Name: TARGET XL 360 SOFT 4MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9269231
• Report Number: 3008881809-2019-00331
• Device Sequence Number: 2616394
• Product Code: HCG
• UDI-Device Identifier: 07613327128390
• UDI-Public: 07613327128390
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2021
• Device Catalogue Number: M0036124080
• Device Lot Number: 20383480
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INZONE DETACHMENT SYSTEM (STRYKER)